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5+delta) protein vaccine (Sf9 cell). The subunit antigen in the vaccine has been based on the structure of the targeting S-RBD and HRproteins of the XBB and BA.5 It is self-assembled into stable trimeric protein particles with the addition of squalene-based oil-in-water emulsion adjuvant following purification and mixing.
The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca.
HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2
1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.
First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).
The vast majority of current laboratory testing for COVID-19 is based either on detection of viral antigens, nucleic acids or on detection of virus-specific antibodies in the sera of patients. Detection of virus-specific antibodies allows for diagnosis of recent symptomatic or even asymptomatic infections.
All current COVID-19 vaccines and antibody-based therapeutics were designed to disrupt this route into cells, which requires a receptor called ACE2. The ability to use an alternative entry pathway opens up the possibility of evading COVID-19 antibodies or vaccines, but the researchers did not find evidence of such evasion.
AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 0.93; p=0.0035).4
months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; PD-L1 staining is the process by which the PD-L1 protein is visualised during testing. months (HR=0.76, 95% CI: 0.54–1.09). months compared with chemotherapy (median OS=20.2 0.89; p=0.0106) in people with high PD-L1 expression (TC3 or IC3-wild-type [WT]). About Tecentriq.
Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,
Maverick’s COBRA platform is used to engineer protein-based therapies that target T cells in the tumor microenvironment to trigger their activation. The biotech acquisition deal includes Five Prime’s prime asset bemarituzumab, which is a first-in-class anti-FGFR2b antibody.
VIKTORIA-1 is a clinical trial aimed at evaluating gedatolisib, a new investigational drug for patients with HR+/HER2-, Stage 3 or 4 breast cancer. More Study Details Study Locations About the Study Breast cancer represents a significant challenge, and advancing treatment options is crucial for patients facing this disease.
months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; months (HR=0.76, 95% CI: 0.54–1.09). PD-L1 is a protein expressed on tumour cells and tumour-infiltrating cells, which suppresses the immune response and enables tumour cells to avoid detection by binding to proteins on the surface of immune cells. receptors.
Patients treated with a short course of five cycles of tremelimumab, an anti-CTLA4 antibody, over 16 weeks in addition to Imfinzi and chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options (based on a hazard ratio [HR] of 0.77; 95% CI 0.65-0.92; 0.92; p=0.00304). Median OS was 14.0
5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 6.45 billion in 2022, a 32.44
The recommendation from the CHMP is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in combination with Avastin reduced the risk of death (overall survival [OS]) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42–0.79; 0.76; p<0.0001), compared with sorafenib.
months in median OS with Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95% CI: 0.53–0.86). The OS data showed a negative trend; however, the study was not powered for the secondary endpoint of OS, and OS data were immature at time of analysis (initial HR=1.55 [95% CI: 0.86-2.80]
The study showed that treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%, 1%, compared with best supportive care (BSC). months for BSC.
Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation. HR-positive breast cancer. GDC-0077 is our next generation investigational PI3K? Ipatasertib.
months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months (HR: 0.51; 95% CI: 0.41-0.62; Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. months from 1.7 0.54; p<0.0001).
In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; 4.3] (HR=0.47; 95% CI 0.31-0.71) is a HER2 directed antibody drug conjugate (ADC).
billion After Biogen and Eisai’s Aduhelm (aducanumab) and Leqembi (lecanemab), donanemab is Eli Lilly’s answer in the beta-amyloid-lowering class of monoclonal antibodies. The companies followed it up with a second BLA submission in patients with HR+, HER2– breast cancer that has been previously treated with systemic therapy.
Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).
Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.
In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) Data from the IMpower010 trial were published simultaneously within the Lancet. 0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1?1%,
For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; 0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; for the placebo arm, with a HR of 0.62 (95% CI, 0.49-0.78; for the placebo arm, with a HR of 0.86 (95% CI, 0.68-1.10).
Imaging techniques such as ultrasound and computerized tomography (CT) are used to visualize structural changes or abnormalities resulting from kidney damage or congenital causes, while urinalysis can be used to detect blood or protein in the urine — another indication of kidney damage. Developed in 1999 2. Expressed in mL/min/1.73m 2.
Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,
Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). Venclyxto blocks the BCL-2 protein and works to help restore the process of apoptosis. The median OS was 14.7 months (95% CI: 11.9,
Trodelvy is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer. More information on TROPiCS-04 is available at [link]. About Trodelvy. About the TROPHY U-01 Study.
The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).
1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]). The BTK protein sends important signals that tell B cells to mature and produce antibodies. 1 Additionally, at 6.5
Enhertu is an antibody-drug conjugate (ADC) consisting of Roche’s Herceptin (trastuzumab), a monoclonal antibody against HER2 (human epidermal growth factor receptor 2), and the topoisomerase I inhibitor deruxtecan. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.
Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.;
months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). TIGIT and PD-L1 are proteins that play a role in suppression of the immune system. Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1.
Why it sold so well: Imbruvica is a kinase inhibitor that targets Bruton’s tyrosine kinase (BTK), a crucial protein in the B-cell receptor signaling pathway. This protein plays a vital role in the survival, growth and movement of malignant B cells. for a 70 mg/mL oral suspension and going up to $22,690.52 months, compared to 14.5
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